Acetylsalicylic Acid Gastro Resistant Tablets BP 100mg

Acetylsalicylic Acid Gastro Resistant Tablets BP 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Acetylsalicylic Acid Gastro Resistant Tablets BP 75mg
2. Acetylsalicylic Acid Gastro Resistant Tablets BP 81mg
3. Acetylsalicylic Acid Gastro Resistant Tablets BP 100mg
4. Acetylsalicylic Acid Gastro Resistant Tablets BP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Acetylsalicylic Acid Gastro Resistant Tablets BP 75mg
Each Gastro Resistant tablet contains:
Acetylsalicylic Acid BP…………….75mg
Excipients……………………………….q.s
Color: Sunset yellow FCF

2. Acetylsalicylic Acid Gastro Resistant Tablets BP 81mg
Each Gastro Resistant tablet contains:
Acetylsalicylic Acid BP…………….81mg
Excipients……………………………….q.s
Color: Sunset yellow

3. Acetylsalicylic Acid Gastro Resistant Tablets BP 100mg
Each Gastro Resistant tablet contains:
Acetylsalicylic Acid BP…………….100mg
Excipients……………………………….q.s
Color: Sunset yellow lake

4. Acetylsalicylic Acid Gastro Resistant Tablets BP 150mg
Each Gastro Resistant tablet contains:
Acetylsalicylic Acid BP…………….150mg
Excipients……………………………….q.s
Color: Ponceau 2R

THERAPEUTIC INDICATIONS:

Acetylsalicylic Acid is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, toothaches, and muscle aches.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
NOT TO BE USED IN CHILDREN BELOW 12 YEARS OF AGE EXCEPT UNDER MEDICAL ADVICE.

IMPORTANT: DO NOT TAKE THIS PRODUCT DURING THE LAST THREE MONTHS OF PREGNANCY UNLESS DIRECTED BY A DOCTOR. ASPIRIN TAKEN NEAR THE TIME OF DELIVERY MAY CAUSE BLEEDING PROBLEMS TO BOTH MOTHER AND CHILD.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Acetylsalicylic Acid Gastro Resistant Tablets BP 100mg: Technical Specifications and Uses

Acetylsalicylic Acid Gastro Resistant Tablets BP, commonly referred to as aspirin in its gastro-resistant form, are a cornerstone in pharmaceutical therapy. Widely recognized for their efficacy, these tablets are engineered to minimize gastric irritation while delivering therapeutic benefits. This comprehensive guide explores the technical specifications, therapeutic uses, precautions, and regulatory details of the product.

Introduction

Acetylsalicylic Acid, popularly known as aspirin, has been a go-to medication for decades. Its gastro-resistant formulation is specifically designed to address concerns of stomach irritation, a common side effect associated with conventional aspirin tablets. Whether for pain relief or anti-inflammatory purposes, these tablets ensure efficacy while prioritizing safety.

Product Specifications

• Brand Name: Generic
• Strengths Available: 75mg, 81mg, 100mg, 150mg
• Dosage Form: Gastro-Resistant Tablets
• Route of Administration: Oral
• Packaging Options: Available in packs of 10, 30, 100, and 500 tablets

This diverse range ensures flexibility for both patients and healthcare providers.

Qualitative and Quantitative Composition

1. 75mg Tablets: Contain Acetylsalicylic Acid BP 75mg, colored with Sunset Yellow FCF.
2. 81mg Tablets: Contain Acetylsalicylic Acid BP 81mg, colored with Sunset Yellow.
3. 100mg Tablets: Contain Acetylsalicylic Acid BP 100mg, colored with Sunset Yellow Lake.
4. 150mg Tablets: Contain Acetylsalicylic Acid BP 150mg, colored with Ponceau 2R.

The excipients used are of pharmaceutical grade, ensuring optimal tablet stability and performance.

Therapeutic Indications

Acetylsalicylic Acid is a versatile medication with multiple therapeutic uses, including:

• Relieving mild to moderate pain such as headaches, muscle aches, and arthritis.
• Reducing fever.
• Managing inflammation in conditions like arthritis.

Mechanism of Action

Acetylsalicylic Acid inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis. This action alleviates pain, inflammation, and fever. The gastro-resistant coating allows the tablet to bypass the stomach, minimizing irritation.

Dosage and Administration

The dosage of Acetylsalicylic Acid should be personalized based on medical advice. Typically:

• Adults: Take as directed by a physician.
• Children (under 12): Not recommended unless prescribed.

Always swallow the tablets whole. Do not chew or crush them.

Precautions and Warnings

• General Precautions: Always read the enclosed leaflet before use.
• Contraindications: Not suitable for individuals allergic to aspirin or with bleeding disorders.
• Pregnancy Warnings: Avoid during the last trimester unless advised by a doctor.

Storage and Handling

• Store at 20°C to 25°C (68°F to 77°F).
• Keep in a dry place away from light and moisture.

Regulatory Documents and Certifications

The product complies with rigorous regulatory standards, including:

• COA (Certificate of Analysis)
• MOA (Method of Analysis)
• Stability Studies
• GMP, COPP, FSC, and CTD Dossier

Manufacturing Details

Taj Pharma, a leader in pharmaceutical manufacturing, operates a WHO-GMP certified facility in India. With cutting-edge technology, their facility ensures consistent quality across their extensive product range.

Benefits of Gastro-Resistant Tablets

The gastro-resistant formulation offers:

• Protection against stomach irritation.
• Consistent therapeutic effects.

FAQs

1. What is the main advantage of gastro-resistant aspirin?
   It reduces stomach irritation compared to regular aspirin.
2. Can children take Acetylsalicylic Acid tablets?
   Only under medical supervision and not recommended for children under 12.
3. What should I do if I miss a dose?
   Take it as soon as you remember, but skip it if it’s close to the next dose.
4. Is it safe during pregnancy?
   Avoid in the third trimester unless advised by a doctor.
5. How should I store the tablets?
   Store them in a cool, dry place, away from light.